Neat AB in Sweden recently requested and obtained the certificates ISO 9001:2008 and ISO 14001:2004. The process was quick and successful thanks to Neat AB easily meets the requirements of these standards.
“This job has been led by Lars Nyström (Business Development Manager) in cooperation with the managers in Sweden. The approval has been done in a very short time, which have been possible because we were already working in a structured way”, Ulrik Lundberg, the R&D Manager and Country Manager, said.
Neat Group in Spain also meets the requirements of the standards ISO9001: 2008 and ISO14001: 2004. Similarly, Neat Group has a strong presence in Australia with its partner TeleMedCare, a company certified with the ISO 13485:2003. That is why the development of its telemedicine solutions follow a strict compliance with the requirements demanded by this standard.
ISO 9001 refers to a generic series of standards published by the ISO that provide quality assurance requirements and quality management guidance. ISO 9000 is a quality system standard, not a technical product standard.
ISO 14001 refers to a series of standards on environmental management tools and systems. ISO 14000 deals with a company’s system for managing its day-to-day operations and how they impact the environment.
ISO 13485 standard is an effective solution to meet the comprehensive requirements for a Quality Management System (QMS). Adopting ISO 13485 provides a practical foundation for manufacturers to address the medical device directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.